Physical Activity and Obesity

Not Applicable

Completed

• Conditions: Sedentary Lifestyle; Obesity; Prediabetic State
• Interventions: Behavioral: High Activity

• Registration Number: NCT02060240
• Lead Sponsor: Oregon Health and Science University

Brief Summary

The purpose of the study is to see if a twelve-week exercise intervention in overweight or obese subjects with pre-diabetes or early disease course type 2 diabetes can lead to improved skeletal muscle capillary blood flow by improving substances that dilate blood vessels and result in improved insulin sensitivity.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-12
• Primary Completion: 2016-04
• Study Completion: 2017-04
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-02
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Males and females ages 30-60 years of age
2. Overweight and Obese (28< BMI <45)
3. Confirmed pre-diabetic (5.7≤ HbA1c < 6.5)
4. Type 2 DM, Diagnosis 2 years or less, on no medications or metformin only, HbA1c ≤ 6.7

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Exclusion Criteria

1. Stage 3 chronic kidney disease (glomerular filtration rate [GFR] < 60)
2. Obstructive Coronary artery disease
3. Congestive heart failure (ejection fraction < 55%)
4. Peripheral vascular disease,
5. Degenerative joint disease, musculoskeletal disease, or peripheral vascular disease that limits ability to exercise
6. Know hypersensitivity to Definity® ultrasound contrast agent
7. Intra-cardiac or pulmonary shunt
8. The use of antithrombotic agents or a severe bleeding diathesis due to risk of bleeding with intravenous and arterial line placement
9. Physical activity greater than three hours per week
10. Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High Activity Group	High Activity	Subject randomized to High Activity group will have 36, one hour training sessions over 12 weeks.

Primary Outcome Measures

Name	Time	Method
Insulin mediated skeletal muslce blood flow and capillary recruitment	3 months	Contrast enhanced ultrasound skeltal muscle perfusion imaging will be performed at rest and during glucose steady state infusion during an insulin clamp. The change in blood flow will be determined between the resting state and at peak steady state to determine the absolute increase in skeletal muslce blood flow (ml/min/g) as well as the absolute increase in capillary blood volume (ml/g) of tissue

Secondary Outcome Measures

Name	Time	Method
Quantification of endothelial derived Vasodilators	3 months	To quantify the changes in endothelial derived vasodilators. For this aim nitric oxide bioavailability as tested by flow mediated vasodilation will be performed and reported as absolute change (cm) and percent change (%) in brachial artery diameter from baseline to post ischemic occlusion of the forearm. Plasma samples for eicosanoids will be collected and assessed by liquid chormatography/mass spectroscopy to to assess changes in endothelial derived vasodilators.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States